MAUDE Adverse Event Report: AVANOS MEDICAL INC. MIC-KEY LOW-PROFILE TRANSGASTRIC-JEJUNAL FEEDING TUBE, 18 FR, 3.0 CM, 45 CM; DH EF BALLOON TUBES PRODUCTS

Model Number	0270-18-3.0-45
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	09/14/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Actual complaint product is reported to be available but was not returned for evaluation.The device history record for the reported lot number, aa7275n32, was reviewed and documented that the lot was manufactured according to the approved manufacturing procedures, specifications, and then released by quality assurance.All information reasonably known as of 03-oct-2018 has been included in this health authority report.Should additional information be obtained, a follow-up health authority report will be provided.The information provided by avanos medical inc represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to avanos medical inc.Avanos medical inc has no independent knowledge of the event reported but is relaying the information that was provided by the user facility where the incident occurred.This product incident is documented in the avanos medical inc complaint database and identified as complaint (b)(4).
Event or Problem Description
It was reported that a patient's gj tube broke inside of him.The patient was scheduled for a 3-month routine tube change.The group home noted no issues with the tube.When a wire was put in and no resistance was felt, it was at that time when they were using fluoroscopy that it was discovered the j-tube detached from the g-tube.They were able to locate the detached portion and removed it.Additional information received on (b)(6) 2018 stated that the patient was an outpatient from a group home with cerebral palsy.It was noted that the patient left in the same condition that he came to them in, and experienced no injury from the tube.On (b)(6) 2018, the customer forwarded avanos medical a copy of the medwatch user facility report they filed reference (b)(4): "on (b)(6) 2018, the patient had a scheduled gastrojejunostomy tube placement.The exchange of the 18 french gastrojejunostomy tube went as planned.Appropriate position was confirmed with contrast injection.Retention balloon was then inflated.No complications were noted.Patient sent back to group home residence.The patient was scheduled for (b)(6), for the next routine gastrojejunostomy tube replacement.The group home had reported no issues with the tube.On (b)(6), during the procedure, the wire was placed in a resistance noted) and discovered when stepped on fluoro that the j-tube portion had detached from the g-tube portion.The interventional radiology team was able snare the broken existing j limb and remove it.The new 18 french gastrojejunostomy tube was inserted through the existing tract into the jejunum.This was a successful replacement of a broken gastrojejunostomy tube with no compromise to our patient.Halyard health was notified of the event." on (b)(6) 2018, avanos medical received user facility report with reference (b)(4).No new information received.
Additional Manufacturer Narrative
Avanos medical received one used mickey tj sample, one bolus extension set, one white step connector, one unidentified wire tied to the distal end of the mickey tj.The mickey tj sample exhibited brown discoloration.The outer surface of the tubing had brown, bumpy clusters adhered to the silicone.The tubing was severed approximately 4 cm below the balloon distal collar.The jejunal port housing was detached from the molded head.The detached feed port was not returned.The subject sample provided was evaluated and confirmed a tube severed approximately 4 cm below the balloon distal collar.However, there were no found activities or tools that could cause this type of flaw in the tube component.Root cause could not be determined.All information reasonably known as of 22-oct-2018 has been included in this health authority report.Should additional information be obtained, a follow-up health authority report will be provided.The information provided by avanos medical inc represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to avanos medical inc.Avanos medical inc has no independent knowledge of the event reported but is relaying the information that was provided by the user facility where the incident occurred.This product incident is documented in the avanos medical inc complaint database and identified as complaint (b)(4).This information is submitted pursuant to 21cfr803, in compliance with the medical device reporting requirement and should not be considered to be an admission that an avanos medical inc product is defective or caused serious injury.
Event or Problem Description
User facility report (b)(4) was received on 16-oct-2018 from the fda.No new information received.

• Brand Name: MIC-KEY LOW-PROFILE TRANSGASTRIC-JEJUNAL FEEDING TUBE, 18 FR, 3.0 CM, 45 CM
• Common Device Name: DH EF BALLOON TUBES PRODUCTS
• Manufacturer (Section D): AVANOS MEDICAL INC.; 5405 windward parkway; alpharetta GA 30004
• MDR Report Key: 7964623
• Report Number: 9611594-2018-00160
• Device Sequence Number: 13805165
• Product Code: KNT
• UDI-Device Identifier: 10680651956672
• UDI-Public: 10680651956672
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: K926581
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,other,use
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/10/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 10/01/2019
• Device Model Number: 0270-18-3.0-45
• Device Catalogue Number: 991095667
• Device Lot Number: AA7275N32
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/10/2018
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 09/17/2018
• Supplement Date Received by Manufacturer: 10/10/2018
• Initial Report FDA Received Date: 10/15/2018
• Supplement Report FDA Received Date: 10/24/2018
• Patient Sequence Number: 1
• Patient Age: 41 YR